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NETS: Nepal Elimination of Trachoma Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02176057
Collaborator
National Eye Institute (NEI) (NIH)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.

  1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease <5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

  2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease <5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

  3. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Nepal Elimination of Trachoma Study
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antibiotic

Azithromycin, suspension (liquid), 1 gram, one-time dose

Drug: Azithromycin
Other Names:
  • Zithromax

    		•
    No Intervention: Observation

    Outcome Measures

    Primary Outcome Measures

    1. Trachoma (clinical and C. trachomatis) [12 months]

    Secondary Outcome Measures

    1. Anthropometry (height for weight) [12 months]

    2. Malaria [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children aged 1-9 years

    • Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

    Exclusion Criteria:

    • All individuals who are allergic to macrolides

    • All pregnant woman

    • All neonates

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Geta Eye Hospital Geta Kailali Nepal 10900

    Sponsors and Collaborators

    • University of California, San Francisco
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Bruce D Gaynor, MD, UCSF F. I. Proctor Foundation (California, USA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT02176057
    Other Study ID Numbers:
    • NETS-13-10961
    • K23EY019881
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    May 21, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by University of California, San Francisco
    trachoma
    Additional relevant MeSH terms:
    Trachoma
    Azithromycin

    Study Results

    No Results Posted as of May 21, 2015